Comparing the cost-effectiveness of two commonly used types of dye for determining whether cancer has spread into the lymphatic system
- Conditions
- Early breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN11807786
- Lead Sponsor
- Manchester University NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 50
1. Participant is willing and able to give informed consent for participation in the study
2. Female aged 18 years or above
3. Diagnosed with breast cancer (invasive) requiring Magseed® localisation and sentinel node biopsy
4. Willing to allow her General Practitioner and consultant, if appropriate, to be notified of participation in the study
5. Undergoing breast-conserving surgery with sentinel node biopsy
6. Surgeons may only operate on the Magtrace arm of the study if they have completed a minimum of five training cases with Magtrace
1. Patients with a pacemaker or implanted device in the chest wall
2. Patients who are pregnant or lactating
3. Patients who have received Magtrace® (iron oxide) injection in the previous 6 months
4. Patients with previous ipsilateral axillary surgery
5. Patients whose breast and axillary surgery are not due to be performed synchronously
6. Patients following neoadjuvant chemotherapy
7. Patients who require MRI follow-up of the ipsilateral breast in the year following surgery (as Magtrace® may interfere with MRI)
8. Patients requiring an interpreter
9. Patients involved in current research or have recently been involved in any research prior to recruitment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cost-effectiveness of Magtrace® compared to Technetium in the identification of sentinel nodes in breast cancer, measured using data records over duration of the study.
- Secondary Outcome Measures
Name Time Method